MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-09-26 for DURASEAL, UNKNOWN XXX-DURASEAL manufactured by Integra Lifesciences Corp.
[121874291]
The device is not expected to be returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[121874292]
A clinical safety operations manager/global patient safety reported that a (b)(6) male patient underwent a suboccipital decompression, c1 laminectomy with partial c2 laminectomy,tonsilopexy and duraplasty with a duraseal dural sealant on (b)(6) 2018. Just prior to discharge, he was noted to have a white blood cell (wbc) count of 12. 8, c-reactive protein (crp) of 116 and mild photophobia. He was discharged from the hospital on (b)(6) 2018. After discharge, the patient had fevers with maximum temperature up to 99. 9. He was re-admitted on (b)(6) 2018. A computed tomography (ct) of head revealed sub-occipital fluid collection along the surgical tract. Wound infection was suspected, no culture was done. Treatment with antibiotics (vancomycin, ceftazidime, cefepime) was started. Patient was discharged on (b)(6) 2018. The event was resolved on 27aug2018. The patient ((b)(6)) is enrolled in a baxter sponsored investigational study titled? A randomised controlled study to evaluate the efficacy and safety of fibrin sealant, vapour heated, solvent/detergent treated (fs vh s/d 500 s-apr) compared to duraseal dural sealant as an adjunct to sutured dural repair in cranial surgery" ; protocol# 3599-001. The investigator of the study assessed the serious adverse events (saes) as possibly related to duraseal and possibly related to the study procedure. The causality assessment by the medical monitor deems that the saes relatedness to duraseal and the study procedure can not be ruled out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2018-00040 |
| MDR Report Key | 7910928 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-26 |
| Date of Report | 2018-09-04 |
| Date of Event | 2018-07-05 |
| Date Mfgr Received | 2018-10-03 |
| Date Added to Maude | 2018-09-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORP |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURASEAL, UNKNOWN |
| Generic Name | DURASEAL CRANIAL |
| Product Code | NQR |
| Date Received | 2018-09-26 |
| Catalog Number | XXX-DURASEAL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORP |
| Manufacturer Address | 311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-26 |